A School-based Prevention Intervention to Promote Wellbeing in Preadolescents (DDS)
Major Risk Factors for Noncommunicable Diseases
Other: Diario della Salute (DDS)
|Study Design:||Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Diario Della Salute (DDS), a School-based Prevention Intervention to Promote Well-being for Grade 7 Students (12-13 Years)|
- Self-reported Social And Emotional Well-Being [ Time Frame: Past 30 Days ] [ Designated as safety issue: No ]Subjective well-being is defined as 'a person's cognitive and affective evaluations of his or her life' (Diener, Lucas, & Oshi, 2002, p. 63).
- Self-reported Cigarette Use [ Time Frame: Past 30 Days ] [ Designated as safety issue: No ]Frequency of cigarette smoking
- Self-reported Drunkenness Episode(s) [ Time Frame: Past 30 Days ] [ Designated as safety issue: No ]Frequency of drunkenness episodes
- Self-reported Dietary Habits [ Time Frame: Past 30 Days ] [ Designated as safety issue: No ]Consumption of beverages and foods such as pop drinks, chips, vegetables, fruits and others
- Self-reported Frequency of Physical Exercise [ Time Frame: Past 30 Days ] [ Designated as safety issue: No ]Frequency of moderate and heavy physical exercise
- Self-reported Physical and Verbal Aggression [ Time Frame: Past 30 Days ] [ Designated as safety issue: No ]Aggression is generally defined as behaviors that are intended to hurt or harm others by damaging their physical and psychological well-being and includes physically and verbally aggressive behaviors such as hitting, pushing, kicking, and threatening, etc (Dodge et al. 2007).
|Study Start Date:||November 2012|
|Study Completion Date:||June 2013|
|Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
Experimental: Intervention group
Preadolescents allocated to the Diario della Salute (DDS) intervention.
Other: Diario della Salute (DDS)
DDS is composed by
|No Intervention: Control group|
Diario della Salute (DDS) is a school-based prevention intervention based on the following theories:
- social-cognitive theory (Bandura, 1977; 1986)
- theory of multiple intelligences (Gardner, 1987)
- emotional intelligence theory (Goleman, 1997)
- theory of planned behavior (Ajzen, 1991)
- transtheoretical model of change (Prochaska, Diclemente, 1982; 1992).
DDS is composed by:
tools for children and their parents on health and social and emotional well-being issues:
- a diary for teens telling the story of four same-age students (e.g. experimenting with risky behaviors, conflicting feelings and thoughts, need for independence and control),
- a diary for parents telling the experience of a mum and a dad with teenage children (e.g. problems in the relationship with teenage children, family conflict, parental disappointment, etc.);
- five highly-standardized interactive lessons (2-4 hours each) on health issues administered by previously trained teachers.
Assignment of schools to study arms (DDS intervention vs. no intervention) will be cluster-randomized. Schools will be matched by number of students and average socioeconomic status. In some study areas schools will not be allocated by chance, but they will be analyzed separately from other schools.
Two anonymous surveys focusing on main outcomes (wellbeing, tobacco smoking, alcohol, physical activity and diet) will be before and after the intervention. Pre and post surveys will be linked through an anonymous code (Galanti, 2006).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01720199
|Azienda Sanitaria Locale CN2 Alba-Bra|
|Alba, Cuneo, Italy, 12051|
|Principal Investigator:||Fabrizio Faggiano, MD||University of Eastern Piedmont|
|Study Chair:||Antonella Ermacora, MSc||Eclectica Sas di Beccaria Franca, Ermacora Antonella e C.|
|Study Director:||Elias Allara, MD||University of Eastern Piedmont|